System and method to deliver therapy in presence of another therapy

ABSTRACT

Various aspects relate to a method. In various embodiments, a therapy of a first therapy type is delivered, and it is identified whether a therapy of a second therapy type is present to affect the therapy of the first therapy type. Delivery of the therapy is controlled based on the presence of the therapy of the second therapy type. Some embodiments deliver the therapy of the first type using one set of parameters in the presence of a therapy of a second type, and deliver the therapy of the first type using another set of parameters when the therapy of the second type is not present. In various embodiments, one of the therapy types includes a cardiac rhythm management therapy, and the other includes a neural stimulation therapy. Other aspects and embodiments are provided herein.

TECHNICAL FIELD

This application relates generally to medical devices and, moreparticularly, to systems, devices and methods to control the delivery oftherapy.

BACKGROUND

Different types of therapies can be delivered simultaneously, or nearsimultaneously, to treat the same condition or to treat differentconditions. For example, it possible to deliver both neural stimulation(NS) therapy and cardiac rhythm management (CRM) therapy.

Some NS therapy can alter cardiac contractility and excitability. Directelectrical stimulation of parasympathetic nerves can activate thebaroreflex, inducing a reduction of sympathetic nerve activity andreducing blood pressure by decreasing vascular resistance. Sympatheticinhibition, as well as parasympathetic activation, have been associatedwith reduced arrhythmia vulnerability following a myocardial infarction,presumably by increasing collateral perfusion of the acutely ischemicmyocardium and decreasing myocardial damage. Modulation of thesympathetic and parasympathetic nervous system with neural stimulationhas been shown to have positive clinical benefits, such as protectingthe myocardium from further remodeling and predisposition to fatalarrhythmias following a myocardial infarction.

SUMMARY

Various aspects of the present subject matter relate to a device. Invarious embodiments, the device comprises at least one port to connectto at least one lead with at least one electrode, stimulator circuitryconnected to the at least one port and adapted to deliver electricalpulses to at least one of the electrodes as part of a first electricaltherapy type, and a controller connected to the stimulator circuitry.The controller is adapted to control delivery of the electrical pulsesusing a plurality of parameters for at least one programmed electricaltherapy of the first electrical therapy type. The controller is adaptedto determine when a therapy of a second electrical therapy type isapplied, provide electrical therapy for the first electrical therapytype using a first set of parameters when the therapy of the secondelectrical therapy type is present to affect the at least one programmedelectrical therapy for the first electrical therapy type, and provideelectrical therapy using a second set of parameters when the therapy ofthe second electrical therapy type is not present.

Various aspects of the present subject matter relate to a method. Invarious embodiments, a therapy of a first therapy type is delivered, andit is identified whether a therapy of a second therapy type is presentto affect the therapy of the first therapy type. Delivery of the therapyis controlled based on the presence of the therapy of the second therapytype. Some embodiments deliver the therapy of the first type using oneset of parameters in the presence of a therapy of a second type, anddeliver the therapy of the first type using another set of parameterswhen the therapy of the second type is not present.

In various embodiments, the first therapy type includes a cardiac rhythmmanagement therapy, and the second therapy type includes a neuralstimulation therapy. In various embodiments, the first therapy typeincludes a neural stimulation therapy and the second therapy typeincludes a cardiac rhythm management therapy.

This Summary is an overview of some of the teachings of the presentapplication and not intended to be an exclusive or exhaustive treatmentof the present subject matter. Further details about the present subjectmatter are found in the detailed description and appended claims. Otheraspects will be apparent to persons skilled in the art upon reading andunderstanding the following detailed description and viewing thedrawings that form a part thereof, each of which are not to be taken ina limiting sense. The scope of the present invention is defined by theappended claims and their equivalents.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a system including an implantable medical device(IMD) and a programmer, according to various embodiments.

FIG. 2 illustrates an embodiment of CRM device, such as can be used inan IMD in the system of FIG. 1.

FIG. 3 illustrates a programmer, such as the programmer illustrated inthe system of FIG. 1, or other external device to communicate with theimplantable medical device(s), according to various embodiments.

FIG. 4 illustrates a system diagram of an embodiment of an implantablemedical device configured for multi-site stimulation and sensing.

FIG. 5 illustrates an implantable medical device (IMD) such as shown inFIG. 1 having a neural stimulation (NS) component and cardiac rhythmmanagement (CRM) component, according to various embodiments.

FIG. 6 illustrates a system including a programmer, an implantableneural stimulator (NS) device and an implantable cardiac rhythmmanagement (CRM) device, according to various embodiments.

FIG. 7 illustrates an implantable neural stimulator (NS) device such ascan be incorporated as the IMD in the system of FIG. 1 or as the neuralstimulator in the system of FIG. 6, according to various embodiments ofthe present subject matter.

FIG. 8 illustrates a device, according to various embodiments, such asthe IMD illustrated in FIG. 1, for example.

FIG. 9 illustrates a device, according to various embodiments, such asthe IMD illustrated in FIG. 1, for example.

FIG. 10 illustrates a method, according to various embodiments.

FIG. 11A illustrates a method for controlling delivery of therapy of thefirst type (e.g. CRM therapy) based on a plurality of parametersorganized into at least two sets and based on whether the therapy of thesecond type (e.g. neural stimulation therapy) is present, according tovarious embodiments.

FIG. 11B illustrates a method for controlling delivery of therapy of thefirst type (e.g. CRM therapy) based the intensity of the therapy of thesecond type (e.g. neural stimulation therapy), according to variousembodiments.

FIG. 11C illustrates a method for controlling delivery of therapy of thefirst type (e.g. CRM therapy) based on whether the therapy of the secondtype (e.g. neural stimulation therapy) is present and on the intensityof the therapy of the second type, according to various embodiments.

FIGS. 12A, 12B and 12C illustrate plurality of parameters, and furtherillustrate the first and second sets of parameters, according to variousembodiments.

DETAILED DESCRIPTION

The following detailed description of the present subject matter refersto the accompanying drawings which show, by way of illustration,specific aspects and embodiments in which the present subject matter maybe practiced. These embodiments are described in sufficient detail toenable those skilled in the art to practice the present subject matter.Other embodiments may be utilized and structural, logical, andelectrical changes may be made without departing from the scope of thepresent subject matter. References to “an”, “one”, or “various”embodiments in this disclosure are not necessarily to the sameembodiment, and such references contemplate more than one embodiment.The following detailed description is, therefore, not to be taken in alimiting sense, and the scope is defined only by the appended claims,along with the full scope of legal equivalents to which such claims areentitled.

The present subject matter relates to a device that delivers a therapyof a first therapy type, identifies whether a therapy of a secondtherapy type is present to affect the therapy of the first therapy type,and controls delivery of the therapy based on the presence of thetherapy of the second therapy type and based on a plurality ofparameters organized into a first set and a second set in at least oneprogrammed therapy for the therapy type. Some embodiments of the presentsubject matter relates to a device that provides a cardiac rhythmmanagement (CRM) type of therapy, such as a pacing therapy and variouspacing modes, a defibrillation therapy, and a cardiac resynchronizationtherapy (CRT), and combinations thereof. The CRM type of therapy isprovided in the presence of neural stimulation (NS) therapy. The CRM andNS therapy can be contained in the same device or in independentimplantable devices that communicate through lead-based or leadlessmeans.

In various embodiments, the CRM device detects, receives an alert orotherwise identifies the presence of neural stimulation, and switchesfrom a first to a second set of pacing and/or defibrillation parametersto account for the presence of neural stimulation. It is known that someneural stimulation can alter, among other things, cardiac conduction,contractility and excitability. The use of the second set of parametersaccounts for such changes induced by the neural stimulation.

In various embodiments, the neural stimulation device detects, receivesan alert or otherwise identifies the presence of the CRM device, andswitches from a first to a second set of neural stimulation parameters.CRM therapy captures cardiac tissue with electrical energy. Theelectrical energy itself can cause problems. An example of switchingfrom a first set of parameter to a second set of parameters includesstimulating a different neural target, or changing a neural stimulationsignal parameter, such as amplitude, frequency, burst timing andmorphology, to compensate for the CRM therapy. Another example providesa neural stimulation therapy to cooperate with CRM therapy, such as bystimulating an SVC-AO cardiac fat pad to selectively controlcontractility for the heart, a PV cardiac fat pad associated with ansinoatrial (SA) node to selectively control a sinus rate, and/or anIVC-LA cardiac fat pad associated with an atrioventricular (AV) node toselectively control AV conduction. In humans, the SVC-AO cardiac fat padis located proximate to a junction between a superior vena cava and anaorta, the PV cardiac fat pad is located proximate to a junction betweena right atrium and right pulmonary vein, and the IVC-LA cardiac fat padis located proximate to a junction between an inferior vena cava andleft atrium. Because fat pad ganglia form part of the efferent pathway,stimulation of cardiac fat pads directly effects cardiac tissue. Forexample, stimulating the parasympathetic efferents can selectivelyaffect rate, and conduction. Stimulation of the parasympathetic pathwayalso has post-ganglionic inhibition of sympathetic outflow.

The cardiac fat pads can be stimulated with epicardial leads withelectrodes placed in or near the target fat pad, withintravascularly-fed leads to transvascularly stimulate the target fatpad from within the vessel, and intravascularly fed leads to piercethrough a vessel wall into the target fat pad. Neural pathways, such asthe vagus nerve trunk and vagal cardiac branches, for example, can bestimulated using a nerve cuff, using an intravascularly-fed leads totransvascularly stimulate the neural target from within the vessel, andintravascularly-fed leads to pierce through a vessel wall into positionproximate to a neural target. Baroreceptors within blood vessel wallscan be stimulated using an intravascularly-fed lead and a stent-likeelectrode positioned proximate to the target baroreceptors.

According to various embodiments, the CRM device identifies the presenceof neural stimulation (e.g. detects the neural stimulation or is alertedby the neural stimulation device). When neural stimulation is identifiedthe device switches from its normal mode to a “neural stimulation mode.”In this mode, the device uses alternate settings for parameters such asV-V interval, A-V interval, anti-tachycardia pacing (ATP) rate,defibrillation threshold, etc. to adapt to the presence of neuralstimulation. The second set of parameters are independently programmablein some embodiments. Some embodiments automatically relate the secondset of parameters to the baseline parameters.

Since neural stimulation can alter cardiac conduction and excitability.Therefore, the appropriate CRM settings during neural stimulation may bedifferent from the appropriate settings in the absence of neuralstimulation. The present subject matter allows the CRM and neuralstimulation devices to continuously provide appropriate therapy.

Various embodiments provide a system, either in one device or in morethan one device, with capabilities to provide CRM and NS therapy, andwith the capability to automatically adjust pacing and defibrillationparameters during neural stimulation to account for altered cardiacconditions. During neural stimulation, some embodiments switch to analternate set of CRM parameters, compensating for cardiac changes causedby neural stimulation. Therefore, the system has two sets of pacing anddefibrillation parameters. The parameters in the sets can be mutually orpartially exclusive of each other. The parameters of one set can be asubset of the parameters in another. The sets can include the sameparameters, but different values for one or more of the parameters. Thesecond set could be, independently programmable or automatically relatedto the baseline parameters.

FIG. 1 illustrates a system 100 including an implantable medical device(IMD) 101 and a programmer 102, according to various embodiments of thepresent subject matter. Various embodiments of the IMD 101 includeneural stimulator functions only, various embodiments include CRMfunctions only, and various embodiments include a combination of NS andCRM functions. The IMD can be designed to deliver other therapies, suchas drug therapies. The IMD and programmer are capable of wirelesslycommunicating data and instructions. In various embodiments, forexample, the programmer and IMD use telemetry coils to wirelesslycommunicate data and instructions. Thus, the programmer can be used toadjust the programmed therapy provided by the IMD, and the IMD canreport device data (such as battery and lead resistance) and therapydata (such as sense and stimulation data) to the programmer using radiotelemetry, for example.

FIG. 1 illustrates an implantable medical device (IMD). Aspects of thepresent subject matter can be practiced using external devices. FIG. 1also illustrates that IMD communicating with a programmer. The IMD canalso wirelessly communicate directly with a personal digital assistantor other electronic device such as would be used in an advanced patientmanagement (APM) system, which can organize and perform calculationsbased on recorded data, and later provide the data to a programmer.

FIG. 2 illustrates an embodiment of CRM device 203, such as can be usedin an IMD in the system of FIG. 1. The illustrated device 203 includes acontroller 204 connected to a memory 205. The figure further illustrateselectrodes 206A and 206B connected to the device. According to theillustration, the electrodes 206A and 206B are connected to sensemodules 207A and 207B to sense electrical signal at the electrode, andpulse generators 208A and 208B to generate stimulation signals to theelectrodes. The controller 204 is connected to the sense modules 207Aand 207B and the pulse generator modules 208A and 208B via interfaces209A and 209B.

The memory includes data and instructions. The controller is adapted toaccess and operate the instructions to perform various functions withinthe device, including programmed CRM therapies. The memory 205 includesa plurality of parameters that are used to control the delivery of thetherapy. The plurality of parameters are organized into at least twosets. A programmed therapy can be performed using either of the at leasttwo sets of parameters. In various embodiments, the controller operateson the instructions to deliver a therapy, such as bradycardia pacing ordefibrillation, of a CRM therapy type is delivered. The controlleridentifies whether a therapy of a second therapy type, such as a neuralstimulation therapy, is present to affect the CRM therapy. Delivery ofthe CRM therapy is controlled based on the presence of the neuralstimulation therapy type. Some embodiments deliver the CRM therapy usingone set of parameters in the presence of a neural stimulation therapyand deliver the CRM therapy using another set of parameters when theneural stimulation therapy is not present.

A transceiver 210 is connected to the controller 204. The CRM device iscapable of wireless communicating with a programmer, for example, usingthe transceiver 210. For example, various embodiments use telemetrycoils to wirelessly communicate data and instructions. In otherembodiments, communication of data and/or energy is by ultrasonic means.

FIG. 3 illustrates a programmer 311, such as the programmer 102illustrated in the system of FIG. 1, or other external device tocommunicate with the implantable medical device(s), according to variousembodiments of the present subject matter. An example of anotherexternal device includes Personal Digital Assistants (PDAs) or personallaptop and desktop computers in an Advanced Patient Management (APM)system. The illustrated device includes controller circuitry 312 and amemory 313. The controller circuitry is capable of being implementedusing hardware, software, and combinations of hardware and software. Forexample, according to various embodiments, the controller circuitryincludes a processor to perform instructions embedded in the memory toperform a number of functions, including communicating data and/orprogramming instructions to the implantable devices. The illustrateddevice 311 further includes a transceiver 314 and associated circuitryfor use to communicate with an implantable device. Various embodimentshave wireless communication capabilities. For example, variousembodiments of the transceiver and associated circuitry include atelemetry coil for use to wirelessly communicate with an implantabledevice. The illustrated device 311 further includes a display 315,input/output (I/O) devices 316 such as a keyboard or mouse/pointer, anda communications interface 317 for use to communicate with otherdevices, such as over a communication network.

The programmer is able to program at least some of the parameters in oneof the parameter sets used by the IMD to provide the therapy. In someembodiments, the IMD automatically determines the second set ofparameters as a function of the programmed first set of parameters. Invarious embodiments, at least some of the parameters in both a first andsecond set of parameters is programmable.

FIG. 4 illustrates a system diagram of an embodiment of an implantablemedical device configured for multi-site stimulation and sensing. Thisdiagram provides another example of an IMD capable of performing anumber of CRM type of therapies. Pacing, as used in the discussion ofthis figure, relates to electrical stimulation. In various embodiments,the stimulation for a given channel includes stimulation to capturemyocardia, neural stimulation or both pacing and neural stimulation.Three examples of sensing and pacing channels are designated “A” through“C”. The illustrated channels comprise bipolar leads with ringelectrodes 418A-C and tip electrodes 419A-C, sensing amplifiers 420A-C,pulse generators 421A-C, and channel interfaces 422A-C. Each of thesechannels thus includes a stimulation channel extending between the pulsegenerator the electrode and a sensing channel extending between thesense amplifier and the electrode. The channel interfaces 422A-Ccommunicate bidirectionally with microprocessor 423, and each interfacemay include analog-to-digital converters for digitizing sensing signalinputs from the sensing amplifiers and registers that can be written toby the microprocessor in order to output pacing pulses, change thepacing pulse amplitude, and adjust the gain and threshold values for thesensing amplifiers. The sensing circuitry detects a chamber sense,either an atrial sense or ventricular sense, when an electrogram signal(i.e., a voltage sensed by an electrode representing cardiac electricalactivity) generated by a particular channel exceeds a specifieddetection threshold. Algorithms, including a number of adjustableparameters, used in particular stimulation modes employ such senses totrigger or inhibit stimulation, and the intrinsic atrial and/orventricular rates can be detected by measuring the time intervalsbetween atrial and ventricular senses, respectively. The AV conductioncan be measured by measuring a time interval between atrial andventricular intrinsic events.

The switching network 424 is used to switch the electrodes to the inputof a sense amplifier in order to detect intrinsic cardiac activity andto the output of a pulse generator in order to deliver stimulation. Theswitching network also enables the device to sense or stimulate eitherin a bipolar mode using both the ring and tip electrodes of a lead or ina unipolar mode using only one of the electrodes of the lead with thedevice housing or can 425 serving as a ground electrode or anotherelectrode on another lead serving as the ground electrode. A shock pulsegenerator 426 is also interfaced to the controller for delivering adefibrillation shock via a pair of shock electrodes 427 to the atria orventricles upon detection of a shockable tachyarrhythmia. Channelinterface 428 and sense amplifier 429 provide a connection between themicroprocessor and the switch to receive a sensed signal from a sensor430 for use to detect a second therapy type such as a neural stimulationtherapy.

The controller or microprocessor controls the overall operation of thedevice in accordance with programmed instructions and a number ofadjustable parameters stored in memory 431, including controlling thedelivery of stimulation via the channels, interpreting sense signalsreceived from the sensing channels, and implementing timers for definingescape intervals and sensory refractory periods. The controller iscapable of operating the device in a number of programmed stimulationmodes which define how pulses are output in response to sensed eventsand expiration of time intervals. Most pacemakers for treatingbradycardia are programmed to operate synchronously in a so-calleddemand mode where sensed cardiac events occurring within a definedinterval either trigger or inhibit a pacing pulse. Inhibited stimulationmodes utilize escape intervals to control pacing in accordance withsensed intrinsic activity such that a stimulation pulse is delivered toa heart chamber during a cardiac cycle only after expiration of adefined escape interval during which no intrinsic beat by the chamber isdetected. Escape intervals for ventricular stimulation can be restartedby ventricular or atrial events, the latter allowing the pacing to trackintrinsic atrial beats. A telemetry interface 432 is also provided whichenables the controller to communicate with an external programmer orremote monitor. Rather than or in addition to interface 428, senseamplifier 429 and sensor 430, some embodiments receive an alert or othercommunication through the telemetry interface or through othercommunication means to identify the presence of another type of therapy.

FIG. 5 illustrates an implantable medical device (IMD) 533 such as shownat 101 in FIG. 1 having a neural stimulation (NS) component 534 andcardiac rhythm management (CRM) component 535, according to variousembodiments of the present subject matter. The illustrated device 533includes a controller 536 and a memory 537. According to variousembodiments, the controller includes hardware, software, or acombination of hardware and software to perform the baroreceptorstimulation and CRM functions. For example, the programmed therapyapplications, including a plurality of parameters organized in at leasttwo parameter sets, discussed in this disclosure are capable of beingstored as computer-readable instructions embodied in memory and executedby a processor. According to various embodiments, the controllerincludes a processor to execute instructions embedded in memory toperform the baroreceptor stimulation and CRM functions. The illustrateddevice 533 further includes a transceiver 538 and associated circuitryfor use to communicate with a programmer or another external or internaldevice. Various embodiments include a telemetry coil.

The CRM therapy section 535 includes components, under the control ofthe controller, to stimulate a heart and/or sense cardiac signals usingone or more electrodes. The CRM therapy section includes a pulsegenerator 539 for use to provide an electrical signal through anelectrode to stimulate a heart, and further includes sense circuitry 540to detect and process sensed cardiac signals. An interface 541 isgenerally illustrated for use to communicate between the controller 536and the pulse generator 539 and sense circuitry 540. Three electrodesare illustrated as an example for use to provide CRM therapy. However,the present subject matter is not limited to a particular number ofelectrode sites. Each electrode may include its own pulse generator andsense circuitry. However, the present subject matter is not so limited.The pulse generating and sensing functions can be multiplexed tofunction with multiple electrodes.

The NS therapy section 534 includes components, under the control of thecontroller, to stimulate a baroreceptor and/or sense ANS parametersassociated with nerve activity or surrogates of ANS parameters such asblood pressure and respiration. Three interfaces 542 are illustrated foruse to provide ANS therapy. However, the present subject matter is notlimited to a particular number interfaces, or to any particularstimulating or sensing functions. Pulse generators 543 are used toprovide electrical pulses to an electrode for use to stimulate abaroreceptor site. According to various embodiments, the pulse generatorincludes circuitry to set, and in some embodiments change, the amplitudeof the stimulation pulse, the frequency of the stimulation pulse, theburst frequency of the pulse, and the morphology of the pulse such as asquare wave, triangle wave, sinusoidal wave, and waves with desiredharmonic components to mimic white noise or other signals. Sensecircuits 544 are used to detect and process signals from a sensor, suchas a sensor of nerve activity, blood pressure, respiration, and thelike. The interfaces 542 are generally illustrated for use tocommunicate between the controller 536 and the pulse generator 543 andsense circuitry 544. Each interface, for example, may be used to controla separate lead. Various embodiments of the NS therapy section onlyinclude a pulse generator to stimulate baroreceptors.

According to various embodiments, the lead(s) and the electrode(s) onthe leads are physically arranged with respect to the heart in a fashionthat enables the electrodes to properly transmit pulses and sensesignals from the heart, and with respect to neural targets to stimulate,and in some embodiments sense neural traffic from, the neural targets.Examples of neural targets include both efferent and afferent pathways,such as baroreceptors, nerve trunks and branches such as the vagusnerve, and cardiac fat pads, to provide a desired neural stimulationtherapy. As there may be a number of leads and a number of electrodesper lead, the configuration can be programmed to use a particularelectrode or electrodes.

The leads of the device include one or more leads to provide CRMtherapy, such as atrial pacing, right and/or left ventricular pacing,and/or defibrillation. The device also contains at least on neuralstimulation lead which is placed in an appropriate location. Someembodiments perform neural stimulation and CRM therapy using the samelead. Examples of neural stimulation leads include: an expandablestimulation lead placed in the pulmonary artery in proximity of a highconcentration of baroreceptors; an intravascularly-fed lead placedproximate to a cardiac fat pad to transvascularly stimulate the fat pad;an epicardial lead with an electrode placed in or proximate to the fatpad; a cuff electrode placed around the aortic, carotid, or vagus nerve;and an intravascularly-fed lead placed to transvascularly stimulate theaortic, carotid or vagus nerve. Other lead placements to stimulate otherneural targets may be used.

The controller controls delivery of the electrical pulses using aplurality of parameters for at least one programmed electrical therapyof a first electrical therapy type. The controller is adapted todetermine when a therapy of a second electrical therapy type is applied,which can be sensed or other communicated via an alert signal. Thecontroller provides electrical therapy for the first electrical therapytype using a first set of parameters when the therapy of the secondelectrical therapy type is present to affect the at least one programmedelectrical therapy for the first electrical therapy type, and provideselectrical therapy using a second set of parameters when the therapy ofthe second electrical therapy type is not present.

In some embodiments, the first electrical therapy type is a CRM type oftherapy, and the second electrical therapy is a neural stimulation typeof therapy. There are a number of therapies of a CRM type. Examplesinclude ventricular defibrillation, atrial defibrillation, pacing suchas bradycardia and tachycardia pacing, and cardiac rhythm managementtherapy. In some embodiments, the second electrical therapy type is aneural stimulation (NS) type of therapy. There are a number of therapiesof an NS type. Examples include anti-hypertension therapy, therapy for amyocardial infarction, and stimulation to selectively control cardiacconduction and contractility. In other embodiments, the first electricaltherapy type is an NS type and the second electrical therapy type is aCRM type.

A plurality of parameters are used by algorithms performed by thecontroller to deliver the desired therapy. Often, these parameters areadjustable. A programmer, for example, is able to adjust parameters inan IMD. The present subject matter organizes the parameters into atleast two sets for a given therapy of the first type. The parameter setused depends on whether the second therapy type is present. Thedifferent parameter sets can represent a different value for at leastone of the parameters, or can represent at least one differentparameter. The different parameter sets can represent different pacingmodes, such as atrial pacing (AOO, AAI), ventricular pacing (VVI, VOO),and or dual chamber pacing (DDI, DDD, VDD), for example. Thus, changingthe parameter set can change the pacing mode. Additionally, changing theparameter set can change values for parameters for a particular pacingmode, such as base rate, upper rate, AV interval, ventricular refractoryand ventricular blanking in a DDD pacing mode.

In some embodiments, the first electrical therapy type is a NS type oftherapy, and the second electrical therapy is a CRM type of therapy.Examples of parameters for neural stimulation include parameters thatcontrol location of the neural target, and that control amplitude,frequency, burst timing (such as burst frequency and burst duration),and morphology.

FIG. 6 illustrates a system 645 including a programmer 646, animplantable neural stimulator (NS) device 647 and an implantable cardiacrhythm management (CRM) device 648, according to various embodiments ofthe present subject matter. Various aspects involve a method forcommunicating between an NS device and a CRM device or other cardiacstimulator. This communication allows one of the devices 647 or 648 todeliver more appropriate therapy (i.e. more appropriate NS therapy orCRM therapy) based on data and/or communication signals received fromthe other device. Some embodiments provide on-demand communications. Theillustrated NS device and the CRM device are capable of wirelesslycommunicating with each other, and the programmer is capable ofwirelessly communicating with at least one of the NS and the CRMdevices. For example, various embodiments use telemetry coils towirelessly communicate data and instructions to each other. In otherembodiments, communication of data and/or energy is by ultrasonic means.In some embodiments, a lead provides a hardwired communication pathbetween the two devices. An example of a CRM device is illustrated inFIGS. 3 and 4.

FIG. 7 illustrates an implantable neural stimulator (NS) device 749 suchas can be incorporated as the IMD 101 in the system 100 of FIG. 1 or asthe neural stimulator 647 in the system 645 of FIG. 6, according tovarious embodiments of the present subject matter. The illustratedneural stimulator 749 includes controller circuitry 750 connected to amemory 751, a sensor 752, a neural stimulation circuitry 753, and atransceiver 754. An electrode is connected to the stimulator circuitry753. The memory includes instructions or algorithms operated on by thecontroller and further includes parameters for use in the algorithms toprovide the desired neural stimulation therapy. Some embodiments use thesensor, such as a neural sensor or other physiologic sensor like a heartrate sensor, to provide feedback for the neural stimulation. Thestimulator circuitry is adapted to adjust parameters of the neuralstimulation signal transmitted to the electrode. According to variousembodiments, one or more of the amplitude, the frequency, the morphologyand the burst timing (frequency and duration of bursts) are capable ofbeing adjusted. The parameters in the memory are organized intoparameter sets to selectively change the neural stimulation, such as byadjusting one or more of the parameters for the neural stimulationsignal, depending on whether another therapy type is present.

FIG. 8 illustrates a device, according to various embodiments of thepresent subject matter, such as the IMD illustrated in FIG. 1, forexample. The illustrated device 855 is adapted to provide a first typeof therapy, and includes a controller 856 connected to stimulatorcircuitry 857 to provide therapy. At least one port 858 is connected tothe stimulator circuitry 857. The port(s) 858 are adapted to connectwith at least one lead 859, with each lead including at least oneelectrode. The lead(s) and electrode(s) are positioned to provide adesired therapy. Each port provides a communication channel to anelectrode.

The controller is adapted to receive an indicator of the presence of asecond type of therapy 860. The controller is adapted to provide atleast one therapy of the first therapy type 861, and is able to operatein two modes. The controller enters one therapy mode 862 which uses afirst parameter set to provide the therapy of the first type when thesecond type of therapy is not present. The controller enters anothertherapy mode 863 which uses a second parameter set to provide thetherapy of the first type when the second type of therapy is present.Thus, even if the therapy of the second type is intermittent in nature,the device is able to continue to deliver the first type of therapy.

FIG. 9 illustrates a device, according to various embodiments of thepresent subject matter, such as the IMD illustrated in FIG. 1, forexample. The illustrated device 955 includes a header section 965 and apulse generator section 964. The pulse generator section includes theprocessing circuitry, and the header provides a physical interface toreceive leads 959 and further provides electrical interfaces via portsto provide communication channels to each lead electrode.

The illustrated device 955 is adapted to provide a first type oftherapy, and includes a controller 956 connected to stimulator circuitry957 to provide therapy. At least one port 958 is connected to thestimulator circuitry 957 via switches 966. Sensor circuitry 967 is alsoconnected to the at least one port 958 via the switches 966. Theswitches are used to allow the same communication channel to be used forboth stimulation and sensing. The sensor circuitry 967 is connected tothe controller 956.

The device 955 further includes memory 968, which includes instructionsand a plurality of adjustable parameters to control the therapy. Asillustrated, the parameters are organized into two parameter sets 969and 970. The controller receives an indicator of the presence of asecond type of therapy, such as a detected therapy via the sensorcircuitry 967 and/or a communicated signal via transceiver 971. Thecontroller is adapted to provide at least one therapy of the firsttherapy type 961, and is able to operate in two modes. The controllerenters one therapy mode 962 which uses a first parameter set 969 toprovide the therapy of the first type when the second type of therapy isnot present. The controller enters another therapy mode 963 which uses asecond parameter set 970 to provide the therapy of the first type whenthe second type of therapy is present.

The present subject matter is capable of automatically adjustingparameters used to deliver therapy of a first type in response towhether therapy of a second type is present. The present subject matteris also capable of automatically adjusting parameters used to delivertherapy of the first type based on the intensity of the therapy of thesecond type. Such embodiments can be based on one or more thresholdintensities that define different intensity levels. Each intensity levelcan be associated with a parameter set. Some embodiments adjust theparameters proportionally to the intensity of the second therapy. Theparameter adjustments can be linearly or nonlinearly related to theintensity change for the therapy of the second type. The parameter setused for the therapy of the first therapy type can be based solely onwhether the therapy of the second therapy type is present, can be basedsolely on an intensity of the therapy of the second therapy type, andcan be based on a combination of whether the therapy of the secondtherapy type is present and the intensity of the therapy of the secondtherapy type.

FIG. 10 illustrates a method, according to various embodiments. At 1072,a therapy (e.g. bradycardia support pacing) of a first type (e.g. CRMtherapy) is delivered. At 1073, it is determined whether a therapy (e.g.neural stimulation of cardiac fat pad) of a second therapy type (neuralstimulation therapy) is present and/or the intensity of the therapy ofthe second type is determined. At 1074, the delivery of therapy of thefirst therapy type is controlled based on a plurality of parametersorganized into at least two sets and based on whether the therapy of thesecond type is present and/or the intensity of the therapy of the secondtype.

FIG. 11A illustrates a method for controlling delivery of therapy of thefirst type (e.g. CRM therapy) based on a plurality of parametersorganized into at least two sets and based on whether the therapy of thesecond type (e.g. neural stimulation therapy) is present, according tovarious embodiments. At 1173, it is determined whether the therapy ofthe second type is present. If the second type of therapy is notpresent, the process proceeds to 1174 where the therapy of the firsttype is delivered using a first parameter set 1174. If the second typeof therapy is present, the process proceeds to 1175 where the therapy ofthe first type is delivered using a second parameter set 1175.

FIG. 11B illustrates a method for controlling delivery of therapy of thefirst type (e.g. CRM therapy) based the intensity of the therapy of thesecond type (e.g. neural stimulation therapy), according to variousembodiments. At 1176, the intensity level of the therapy of the secondtype is determined. The determination of the intensity level can be usea few distinct levels separated by threshold values, such as a high andlow intensity, or can more precisely quantify the intensity levelthroughout the continuum from the lowest to highest intensities. At1177, therapy of the first type is delivered using a parameter setselected based on the intensity level determined at 1176.

FIG. 11C illustrates a method for controlling delivery of therapy of thefirst type (e.g. CRM therapy) based on whether the therapy of the secondtype (e.g. neural stimulation therapy) is present and on the intensityof the therapy of the second type, according to various embodiments. At1178, it is determined whether therapy of the second type is present. Ifthe therapy of the second type is not present, the process proceeds to1179, where therapy of the first type is delivered using a parameter setselected for situations without the therapy of the second type. If thetherapy of the second type is present, the process proceeds to 1180where the intensity level of the therapy of the second type isdetermined, and to 1181 where the therapy of the first types isdelivered using a parameter set selected based on the intensity level.

FIGS. 12A, 12B and 12C illustrate plurality of parameters, and furtherillustrate the first and second sets of parameters, according to variousembodiments. FIG. 12A illustrates a first set and a second set in whichthe sets are exclusive of each other. That is, the sets are defined andorganized to be mutually exclusive such that each set includes distinctparameters with respect to the other set. FIG. 12B illustrates a firstset and a second set that are at least partially inclusive, beingdefined and organized to share at least some parameters. FIG. 12Cillustrates a first set that is a subset of the second set. In additionto the illustrated relationships between the first and second sets, someembodiments may include sets with the same parameters, where thedifferences between the parameter sets are provided by differentadjustable or programmable values of the parameters.

In some embodiments, all of the adjustable parameters in each parameterset are independently programmable. In some embodiments, the adjustableparameters in one parameter set is programmable, and the adjustableparameters in the other parameter set are automatically adjusted as afunction of the values for the parameters in the first parameter set.

One of ordinary skill in the art will understand that, the modules andother circuitry shown and described herein can be implemented usingsoftware, hardware, and combinations of software and hardware. As such,the illustrated modules and circuitry are intended to encompass softwareimplementations, hardware implementations, and software and hardwareimplementations.

The methods illustrated in this disclosure are not intended to beexclusive of other methods within the scope of the present subjectmatter. Those of ordinary skill in the art will understand, upon readingand comprehending this disclosure, other methods within the scope of thepresent subject matter. The above-identified embodiments, and portionsof the illustrated embodiments, are not necessarily mutually exclusive.These embodiments, or portions thereof, can be combined. For example,various embodiments combine two or more of the illustrated processes.Two or more sensed parameters can be combined into a composite parameterused to provide a desired CRM therapy. In various embodiments, themethods provided above are implemented as a computer data signalembodied in a carrier wave or propagated signal, that represents asequence of instructions which, when executed by a processor cause theprocessor to perform the respective method. In various embodiments,methods provided above are implemented as a set of instructionscontained on a computer-accessible medium capable of directing aprocessor to perform the respective method. In various embodiments, themedium is a magnetic medium, an electronic medium, or an optical medium.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat any arrangement which is calculated to achieve the same purpose maybe substituted for the specific embodiment shown. This application isintended to cover adaptations or variations of the present subjectmatter. It is to be understood that the above description is intended tobe illustrative, and not restrictive. Combinations of the aboveembodiments as well as combinations of portions of the above embodimentsin other embodiments will be apparent to those of skill in the art uponreviewing the above description. The scope of the present subject mattershould be determined with reference to the appended claims, along withthe full scope of equivalents to which such claims are entitled.

1. A device, comprising: at least one port to connect to at least onelead with at least one electrode; stimulator circuitry connected to theat least one port and adapted to deliver electrical pulses to at leastone of the electrodes as part of a first electrical therapy type; and acontroller connected to the stimulator circuitry to control delivery ofthe electrical pulses using a plurality of parameters for at least oneprogrammed electrical therapy of the first electrical therapy type, thecontroller being adapted to determine when a therapy of a secondelectrical therapy type is applied, provide electrical therapy for thefirst electrical therapy type using a first set of parameters when thetherapy of the second electrical therapy type is present to affect theat least one programmed electrical therapy for the first electricaltherapy type, and provide electrical therapy using a second set ofparameters when the therapy of the second electrical therapy type is notpresent.
 2. The device of claim 1, further comprising sensor circuitryconnected to the at least one port and adapted to sense intrinsicsignals from at least one of the electrodes, the controller beingconnected to the sensor circuitry and being adapted to control deliveryof the electrical pulses using the sensed intrinsic signals along withthe plurality of parameters.
 3. The device of claim 1, wherein the firstelectrical therapy type is a cardiac rhythm management therapy and thesecond electrical therapy type is a neural stimulation therapy.
 4. Thedevice of claim 3, wherein a first pacing mode uses the first set ofparameters and a second pacing mode uses the second set of parameters.5. The device of claim 3, wherein the at least one programmed electricaltherapy for the first electrical therapy type includes a demand pacingtherapy.
 6. The device of claim 5, wherein the demand pacing therapyincludes a parameter for an anti-tachycardia pacing (ATP) rate, thefirst set of parameters including a first value for the ATP rate, thesecond set of parameters including a second value for the ATP rate. 7.The device of claim 5, wherein the demand pacing therapy includes aparameter for an AV interval, the first set of parameters including afirst value for the AV interval, the second set of parameters includinga second value for the AV interval.
 8. The device of claim 5, whereinthe demand pacing therapy includes a parameter for a VV interval, thefirst set of parameters including a first value for the VV interval, thesecond set of parameters including a second value for the VV interval.9. The device of claim 5, wherein the demand pacing therapy includes afirst pacing mode with the first set of parameters and a second pacingmode with the second set of parameters.
 10. The device of claim 3,wherein the at least one programmed electrical therapy for the firstelectrical therapy type includes a defibrillation therapy.
 11. Thedevice of claim 10, wherein the defibrillation therapy includes aparameter for defibrillation threshold, the first set of parametersincluding a first value for the defibrillation threshold, the second setof parameters including a second value for the defibrillation threshold.12. The device of claim 1, wherein the first electrical therapy type isa neural stimulation therapy and the second electrical therapy type is acardiac rhythm management therapy.
 13. The device of claim 12, whereinthe first set of parameters includes a first value for an amplitude of aneural stimulation signal, and the second set of parameters includes asecond value for the amplitude.
 14. The device of claim 12, wherein thefirst set of parameters includes a first value for a frequency of aneural stimulation signal, and the second set of parameters includes asecond value for the frequency.
 15. The device of claim 12, wherein thefirst set of parameters includes a first value associated with bursttiming for a neural stimulation signal, and the second set of parametersincludes a second value associated with the burst timing.
 16. The deviceof claim 12, wherein the first set of parameters includes a first valuefor a morphology of a neural stimulation signal, and the second set ofparameters includes a second value for the morphology.
 17. The device ofclaim 12, wherein the first set of parameters includes a value for atleast one of an amplitude, a frequency, burst timing, and a morphologyfor a neural stimulation signal, and the second set of parametersincludes a value for at least one other of an amplitude, a frequency,burst timing, and a morphology for a neural stimulation signal.
 18. Thedevice of claim 1, wherein the first set of parameters and the secondset of parameters are independently programmable.
 19. The device ofclaim 1, wherein one set of the first and second sets of parameters is aprogrammable set, and the other set of the first and second sets ofparameters is automatically determined as a function of the programmableset.
 20. The device of claim 1, wherein all of the first set ofparameters is exclusive of all of the second set of parameters.
 21. Thedevice of claim 1, wherein the first set of parameters and the secondset of parameters include some mutual parameters.
 22. The device ofclaim 1, wherein the first set of parameters includes a first parametervalue for a programmable parameter, and the second set of parametersincludes a second parameter value for the programmable parameter that isdifferent from the first parameter value.
 23. The device of claim 1,wherein the device includes an implantable medical device.
 24. Thedevice of claim 1, wherein the device is adapted to provide both thetherapy of the first electrical therapy type and the therapy of thesecond electrical therapy type.
 25. The device of claim 1, wherein thedevice is adapted to sense the therapy of the second electrical therapytype.
 26. The device of claim 1, wherein the device is adapted toreceive an alert when the therapy of the second electrical therapy typeis applied.
 27. A device, comprising: means for delivering a therapy ofa first therapy type; means for identifying whether a therapy of asecond therapy type is present to affect the therapy of the firsttherapy type; and means for controlling delivery of the therapy based onthe presence of the therapy of the second therapy type and based on aplurality of parameters, wherein the means for controlling deliveryincludes: means for controlling delivery of the therapy based on aplurality of parameters organized into a first set and a second set inat least one programmed therapy for the therapy type; means fordelivering the therapy of the first therapy type using the first set ofparameters when a therapy of the second therapy type is present; andmeans for delivering the therapy of the first therapy type using thesecond set of parameters when the therapy of the second therapy type isnot present.
 28. The device of claim 27, wherein the means fordelivering therapy includes means for delivering electrical pulses. 29.The device of claim 27, wherein the means for controlling delivery ofthe therapy based on the presence of the therapy of the second therapytype includes means for sensing for the presence of the therapy of thesecond therapy type.
 30. The device of claim 27, wherein the means forcontrolling delivery of the therapy based on the presence of the therapyof the second therapy type includes means for receiving a signalindicative of delivery of therapy of the second therapy type.
 31. Thedevice of claim 27, wherein the first therapy type includes a cardiacrhythm management (CRM) therapy type, and the second therapy typeincludes a neural stimulation (NS) therapy type.
 32. The device of claim27, wherein the first therapy type includes a neural stimulation (NS)therapy type, and the second therapy type includes a cardiac rhythmmanagement (CRM) stimulation therapy type.
 33. A method, comprising:delivering a therapy of a first therapy type; identifying whether atherapy of a second therapy type is present to affect the therapy of thefirst therapy type; controlling delivery of the therapy based on thepresence of the therapy of the second therapy type, wherein controllingdelivery includes: controlling delivery of the therapy based on aplurality of parameters organized into a first set and a second set inat least one programmed therapy for the therapy type; delivering thetherapy of the first therapy type using the first set of parameters whena therapy of the second therapy type is present; and delivering thetherapy of the first therapy type using the second set of parameterswhen the therapy of the second therapy type is not present.
 34. Themethod of claim 33, wherein delivering therapy includes deliveringelectrical pulses.
 35. The method of claim 33, wherein controllingdelivery of the therapy based on the presence of the therapy of thesecond therapy type includes sensing for the presence of the therapy ofthe second therapy type.
 36. The method of claim 33, wherein controllingdelivery of the therapy based on the presence of the therapy of thesecond therapy type includes receiving a signal indicative of deliveryof therapy of the second therapy type.
 37. The method of claim 33,wherein the first therapy type includes a cardiac rhythm management(CRM) therapy type, and the second therapy type includes a neuralstimulation (NS) therapy type.
 38. The method of claim 33, wherein thefirst therapy type includes a neural stimulation (NS) therapy type, andthe second therapy type includes a cardiac rhythm management (CRM)stimulation therapy type.
 39. A method, comprising: delivering a therapyof a first therapy type; determining an intensity for a therapy of asecond therapy type; and controlling delivery of the therapy of thefirst therapy type based on the intensity of the therapy of the secondtherapy type, including delivering the therapy of the first therapy typeusing a parameter set selected based on the intensity of the therapy ofthe second therapy type.
 40. The method of claim 39, further comprising:determining whether the therapy of the second type is present,delivering therapy of the first type using a parameter set selected foruse when the therapy of the second type is not present; and deliveringthe therapy of the first therapy type using the parameter set selectedbased on the intensity of the therapy of the second therapy type whenthe therapy of the second type is present.
 41. The method of claim 39,wherein the first therapy type is a cardiac rhythm management therapyand the second therapy type is a neural stimulation therapy.
 42. Themethod of claim 39, wherein the first therapy type is a neuralstimulation therapy and the second therapy type is a cardiac rhythmmanagement therapy.